PB1109 - Coaguchek® Pro II performance evaluation to assess direct oral anticoagulants action. The DOAC-Check study.

Tuesday, July 12, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Co-Author(s)

CL

Cristina Legnani

PhD
Arianna Anticoagulazione Foundation
Bologna, Emilia-Romagna, Italy
MC

Michela Cini

PhD
Arianna Anticoagulazione Foundation
Bologna, Emilia-Romagna, Italy

Presenting Author(s)

ST

Sophie Testa

MD
Cremona Hospital
Cremona, Lombardia, Italy

Co-Author(s)

AT

Alberto Tosetto

MD
Vicenza Hospital
Vicenza, Veneto, Italy
CD

Claudia Dellanoce

MSc in biology
Azienda Ospedaliera Istituti Ospitalieri di Cremona, Centro Emostasi e Trombosi
Cremona, Lombardia, Italy
SB

Stefania Bellesso

MSc in biology
Vicenza Hospital
Vicenza, Veneto, Italy
GC

Giuseppe Carli

MD
Vicenza Hospital
Vicenza, Veneto, Italy
IN

Ilaria Nichele

MD
Vicenza Hospital
Vicenza, Veneto, Italy
LL

Laura Lissandrini

MSc in biology
Vicenza Hospital
Vicenza, Veneto, Italy
SZ

Serena Zorzi

Clinical Trial Assistant
Arianna Anticoagulazione Foundation
Bologna, Emilia-Romagna, Italy
EA

Emilia Antonucci

Project Director
Arianna Anticoagulazione Foundation
Bologna, Emilia-Romagna, Italy
GP

Gualtiero Palareti

Vascular doctor
Arianna Anticoagulazione Foundation
Bologna, Emilia-Romagna, Italy

Background: Direct oral anticoagulants (DOACs) do not require routine laboratory monitoring, which is suggested in specific conditions, especially emergencies. Specific tests for DOAC are available, though implemented in few laboratories. PT and aPTT may be useful for a rough evaluation of anticoagulation level but are performed in laboratory, and results are delayed by sample transportation and handling. Conversely, POCT for PT and aPTT measurements are currently used.

Aims: The DOAC-CHECK Study, an observational, national, multicentre, no-profit study, aimed to evaluate weather CoaguChek® Pro II (Roche Diagnostics) use can provide reliable information in DOAC treated patients. The study, promoted by Fondazione Arianna Anticoagulazione, was approved by medical ethics committees and informed consent was obtained from enrolled patients. The study was supported by Roche Diagnostics.

Methods: The study was carried out in two FCSA (Italian Federation of Thrombosis Centers) centers. PT and aPTT were performed by CoaguChek® Pro II using capillary blood; at the same time venous samples were collected for measuring DOAC levels by chromogenic assay (Diagnostica Stago). ROC curves were used to identify the PT and aPTT values (in seconds) that better discriminate DOAC levels > 50 ng/ml, and CoaguChek® Pro II performance was than evaluated.

Results: 512 patients were enrolled; 222 received apixaban, 120 edoxaban, 111 rivaroxaban, and 59 dabigatran (see table 1). The negative predictive values (NPVs) for PT and aPTT were high for edoxaban and rivaroxaban, but lower for dabigatran and apixaban. Taken altogether patients receiving edoxaban and rivaroxaban, a PT ≤ 12.7 sec could exclude DOAC levels > 50 ng/ml in about 95% of the cases [NPV 94.6% (95% CI: 88.1-97.6)].

Conclusion(s): From our data it seems that in patients receiving edoxaban or rivaroxaban the PT performed by CoaguChek® Pro II could be useful for ruling out values above 50 ng/ml.